MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE 45X45 DELIVERY SHEATH; CATHETER, PERCUTANEOUS

Catalog Number	9-TV45X45-12F-080
Medical Device Problem Codes	Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 20mm amplatzer amulet left atrial appendage occluder was selected for a procedure on (b)(6) 2024 using a 12f amplatzer torqvue 45x45 delivery sheath.During the procedure it was noted that it was difficult to advance the device through the sheath due to a kink on the delivery sheath.The delivery sheath was not replaced.The loader was immediately connected to the sheath after removal of the guidewire.After the device was positioned on the appendage the patient presented with st elevations.No interventions were performed and the st elevation resolved on its own after 10 minutes.The device was implanted.The patient did not present with any other clinical signs or symptoms.It was believed that the st elevations were caused by an air embolism but no air bubbles were visualized.The patient status was stable.
Additional Manufacturer Narrative
An event of difficulty advancing the device, material bent/twist and air embolism were reported.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported material twisted/bent could not be conclusively determined.The reported difficult to advance was due to reported material bent.It was also believed that the st elevations were caused by an air embolism but no air bubbles were visualized.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that a 20mm amplatzer amulet left atrial appendage occluder was selected for a procedure on (b)(6) 2024 using a 12f amplatzer torqvue 45x45 delivery sheath.During the procedure it was noted that it was difficult to advance the device through the sheath due to a kink on the delivery sheath.The delivery sheath was not replaced.The loader was immediately connected to the sheath after removal of the guidewire.After the device was positioned on the appendage the patient presented with st elevations.No interventions were performed and the st elevation resolved on its own after 10 minutes.The device was implanted.The patient did not present with any other clinical signs or symptoms.It was believed that the st elevations were caused by an air embolism but no air bubbles were visualized.The patient status was stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• Brand Name: AMPLATZER TORQVUE 45X45 DELIVERY SHEATH
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19241923
• Report Number: 2135147-2024-01981
• Device Sequence Number: 6968455
• Product Code: DQY
• UDI-Device Identifier: 05415067025883
• UDI-Public: (01)05415067025883(17)260430(10)9040201
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K163000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 9-TV45X45-12F-080
• Device Lot Number: 9040201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER AMULET LAA OCCLUDER, 9-ACP2-007-020
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 72 YR
• Patient Sex: Female